Reilly Samantha M, Cheng Tianrong, DuMond Jenna
Office of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, MD.
Tob Regul Sci. 2020 Jul;6(4):242-265. doi: 10.18001/TRS.6.4.3.
We assessed how many peer-reviewed publications reporting chemical quantities and/or yields from electronic nicotine delivery systems (ENDS) have included adequate method validation characteristics in the publication for appropriate interpretation of data quality for informing tobacco regulatory science.
We searched 5 databases (Web of Knowledge, PubMed, SciFinder, Embase, EBSCOhost) for ENDS publications between January 2007 and September 2018. Of the 283 publications screened, 173 publications were relevant for analysis. We identified the publications that report a certain degree of control in data quality, ie, the publications that report marginally validated methods (MVMs). MVMs refer to the methods that: (1) report 3 or more International Conference on Harmonisation (ICH) method validation characteristics, (2) state the method was validated, (3) cite their own previous publication(s) that report MVMs, or (4) use a method within the accreditation scope of an accredited laboratory.
Overall, 97 publications (56%) report MVMs in their studies. This percentage also reflects the publication distribution for the majority of the 28 chemicals measured by MVMs.
This study highlights the need for reporting sufficient validation characteristics following appropriate guidance to ensure the accuracy and reliability of the published analytical data for proper data interpretations that may support policy.
我们评估了有多少报道电子尼古丁传送系统（ENDS）化学物质含量和/或产量的同行评审出版物在其出版物中包含了足够的方法验证特征，以便对数据质量进行恰当解释，从而为烟草监管科学提供信息。
我们在5个数据库（Web of Knowledge、PubMed、SciFinder、Embase、EBSCOhost）中搜索了2007年1月至2018年9月期间关于ENDS的出版物。在筛选的283篇出版物中，173篇与分析相关。我们确定了那些在数据质量方面有一定程度控制的出版物，即那些报道了边际验证方法（MVM）的出版物。MVM是指那些：（1）报告3项或更多国际协调会议（ICH）方法验证特征的方法；（2）声明该方法已得到验证的方法；（3）引用其自己之前报道MVM的出版物的方法；或（4）使用经认可实验室认可范围内方法的方法。
总体而言，97篇出版物（56%）在其研究中报告了MVM。这个百分比也反映了通过MVM测量的28种化学物质中大多数的出版物分布情况。
本研究强调了需要遵循适当的指导报告足够的验证特征，以确保所发表分析数据的准确性和可靠性，以便进行可能支持政策的恰当数据解释。
